Posted on 26 Nov 2021

Regulatory News November

FDA issues draft guidance on “Benefit-Risk Assessment for New Drug and Biological Products”. “The intent of this guidance is to provide drug sponsors and other stakeholders with a clearer understanding of how considerations about a drug’s benefits, risks, and risk management options factor into certain FDA pre- and postmarket regulatory decisions about new drug applications (NDAs) submitted under the Federal Food, Drug and Cosmetic Act (FD&C Act) and biologics license applications” (Federal Register announcement).

EMA’s latest updates on COVID-19 vaccines and treatments. EMA’s recent communications on COVID-19 vaccines:

EMA’s "Human Medicines Highlights" Newsletter. You can access the Newsletter by clicking here. Previous editions can also be found on this page.